PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES

K061790 · Protein Polymer Technologies, Inc. · KRD · Sep 19, 2006 · Cardiovascular

Device Facts

• Record ID: K061790
• Device Name: PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
• Applicant: Protein Polymer Technologies, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Sep 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PVA Plus™, MaxiStat™, and MicroStat™ PVA Foam Embolization Particles may be used for vascular occlusion of blood vessels within the neurovascular and peripher a vascular system. They are intended for arterial embolization of arteriovenous malformations (AVMs) and hypervascular turnors in the peripheral vasculature, and for vascular occlusion of blood vessels within the neurovascular system for the embolization of AVMs and neoplastic lesions.

Device Story

Nonabsorbable synthetic polyvinyl alcohol (PVA) foam particles; uncolored; no additives. Available in range of particle sizes. Delivered to target vascular location via syringe through infusion catheter. Used by clinicians for vascular occlusion of AVMs and hypervascular tumors in peripheral and neurovascular systems. Provides mechanical occlusion of blood vessels to treat lesions/tumors.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical in vitro and in vivo performance testing.

Technological Characteristics

Nonabsorbable synthetic polyvinyl alcohol (PVA) foam particles. Uncoated, no colorants or additives. Range of particle sizes. Delivered via syringe and infusion catheter.

Indications for Use

Indicated for arterial embolization of arteriovenous malformations (AVMs) and hypervascular tumors in the peripheral vasculature, and for vascular occlusion of blood vessels within the neurovascular system for the embolization of AVMs and neoplastic lesions.

Regulatory Classification

Identification

A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

Special Controls

*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).

Predicate Devices

• PVA Plus™ Foam Embolization Particles (K053548)
• MaxiStar™ PVA Foam Embolization Particles (K053548)
• MicroStat™ PVA Foam Embolization Particles (K053548)
• Contour SETM Microspheres (K034068)
• Contour® Emboli PVA (K030966)
• Embosphere® Microspheres (K021397)

Submission Summary (Full Text)

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### 5.0 510(k) SUMMARY

In accordance with Title 21 of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

SEP 1 9 2006

## 5.1 Submitted By

Protein Polymer Technologies, Inc. (PPTI) 10655 Sorrento Valley Road, San Diego, California 92121 Telephone: [phone]

Radine Ganz Pobuda, RAC Contact: Director, Quality Systems & Regulatory Affairs

Date Prepared: May 5, 2006

#### 5.2 Device Name

| | Trade or Proprietary Names: | <i>PVA Plus</i> ™ Foam Embolization Particles |
|--|-----------------------------|-----------------------------------------------------|
| | | <i>MaxiStat</i> ™ PVA Foam Embolization Particles |
| | | <i>MicroStat</i> ™ PVA Foam Embolization Particles |
| | Common or Usual Name: | Polyvinyl alcohol (PVA) foam embolization particles |
| | Classification Name: | Vascular embolization device |

#### ર્ટ.૩ Predicate Devices

The subject devices are substantially equivalent to the following predicate devices:

- PVA Plus™ Foam Embolization Particles (PPTI; K053548) .
- . MaxiStar™ PVA Foam Embolization Particles (PPTI; K053548)
- MicroStat™ PVA Foam Embolization Particles (PPTI; K053548) .
- Contour SETM Microspheres (Boston Scientific; K034068)
- . Contour® Emboli PVA (Boston Scientific; K030966)
- Embosphere® Microspheres (Biosphere Medical; K021397) .

### Device Description 5.4

The subject devices are particles of nonabsorbable synthetic polyvinyl alcohol (PVA) foam. The devices do not contain any colorant or other additive, and are uncol ted. Each is offered in a range of particle sizes, from which the clinician may saleot the particle size most appropriate for the desired effect and targeted vasculature. The devices are delivered to the selected vascular location by means of a syringe, through an infusion catheter of diameter appropriate for the selected particle size. The subject devices are manufactured for PPT by Surgica Corporation, 5090 Robert J. Matthews Parkway, No. 4, El Dorado Hills, CA 95762.

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# 5.5 Intended Use

PVA Plus™, MaxiStat™, and MicroStat™ PVA Foam Embolization Particles may be used for vascular occlusion of blood vessels within the neurovascular and peripher a vascular system. They are intended for arterial embolization of arteriovenous malformations (AVMs) and hypervascular turnors in the peripheral vasculature, and for vascular occlusion of blood vessels within the neurovascular system for the embolization of AVMs and neoplastic lesions.

## ર્ટ ર્ Comparison to Predicate Devices

The subject devices do not differ in any regard from PPTI's predicate PVA Plus™ MaxiStar™, and MicroStat™ devices currently cleared for market in the U.S. Further, the subject devices are substantially equivalent to other predicate devices cleared for commercial distribution in the U.S., in terms of material composition, particle configuration, range of sizes offered, biocompatibility, packaging, how supplied, indications, and method of use. Among these predicates are the Contour® Emboli PVA and Contour SE™ Microsphere devices marketed by Boston Scientific (K030966 and K034068, respectively), and Embosphere® Microspheres, marketed by Biosphere Medical (K021397).

# 5.7 Summary of Non-Clinical Tests

Nonclinical tests, both in vitro and in vivo, have demonstrated the substantial equivalence of the subject devices to commercially-available predicates in terms of performance.

### 5.8 Summary of Clinical Tests

(Not applicable)

# 5.9 Conclusions of Non-Clinical and Clinical Tests

The results of all testing demonstrated the substantial equivalence of the subject devices to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Protein Polymer Technologies, Inc. % Radine Pobuda, RAC Director, Quality Systems and Regulatory Affairs 10655 Sorrento Valley Road San Diego, California 92121

SEP 1 9 2006

Re: K061790

Trade/Device Name: PVA Plus™ Foam Embolization Pareticles; MaxiStat™ PVA Foam Embolization Particles: and MicroStat™ PVA Foam Embolization Particles Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular embolization device Regulatory Class: II Product Code: KRD, HCG Dated: June 23, 2006 Received: June 26, 2006

Dear Radine Pobuda:

We have reviewed your Section 510/k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Radine Pobuda, RAC

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free nuraber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Protein Polymer Technologies, Inc

# Indications for Use

510(k) Number (if known): K061790

PVA Plus™ Foam Embolization Particles; Device Names: MaxiStar™ PVA Foam Embolization Particles; and MicroStat™ PVA Foam Embolization Particles

Indications for Use:

PVA particles are indicated for arterial embolization of arteriovenous malformations (AVMs) and hypervascular tumors in the peripheral vasculature, and for vascular occlusion of blood vessels within the neurovascular system for the embolization of AVMs and neoplastic lesions.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

ಕ್ಟಾ. ಸ

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-On)

Division of General, Restorative,
and Neurological Devices

510(k) Number: 061790